CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead
by Medtronic Cardiac Rhythm Disease Management PMA
Active
PMA P850089
Overview
This device is a permanent pacemaker electrode, designed for transvenous implantation to deliver electrical stimulation to the heart. It facilitates cardiac pacing by transmitting pacing pulses to the right atrium or ventricle, ensuring proper heart rhythm in patients with bradycardia or conduction disorders.
The leads are supplied sterile and intended for single-use implantation, though they may be compatible with certain reusable pacemaker systems. They are classified as Class III devices under FDA regulations and are approved for use in cardiovascular procedures. Storage requires adherence to sterile packaging instructions, and compatibility should be verified with the connected pacemaker system before implantation.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP850089 | Date29 Jul 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- Capsure Sp, Capsure, Capsure 2 Leads, Excellence S, Impulse, Impluse Ii Excellence Ss, Leads
- Generic Name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- PMA Number
- FDA Product Code
- NVN
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
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